A first-in-human trial requires a cautious, strategic approach, especially when early data suggest cardiovascular and seizure risk. That was the case for this integrated dose-escalation trial in healthy volunteers, which required intensive safety monitoring, morning dosing, and complex PK/PD sampling.
In this case study, discover how Clinilabs safeguarded study subjects and ensured protocol integrity by:
- Designing a protocol that integrated intensive ECG/EEG safety monitoring
- Recommending orthostatic vital sign assessments to uncover fainting events
- Negotiating a revised dosing schedule that balanced risk and timelines
- Delivering clean, high-quality data with zero major protocol deviations
With experience across 800+ CNS trials, Clinilabs brings the foresight and flexibility early-phase studies need to succeed.
